Ms. Goldstein has over 20 years experience in the medical device industry developing and managing Quality Systems for compliance with FDA, ISO and Canadian regulations. She has held increasing roles of responsibility in Quality Management and Quality Engineering capacities with companies such as GI Dynamics, Transmedics, Medispectra, MEdtronic and C.R. Bard. Ms. Goldstein is an active leader for the ASQ Biomedical Division, and sits on the board for the ASQ Biomedical Division New England Discussion Group. She is an ASQ Certified Manager of Quality/Organization Excellence and Certified Quality Engineer.